Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia

NCT02079311 | Completed Results

• 1 other identifier: MD13-001
• Study Type: interventional
• Target: 55
• Locations: 3 countries
• Sites: 3

Brief Summary

This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm active self-warming blanket differs compared to active warming with forced air warming in terms of core body temperature perioperatively. A non-inferiority, prospective, open-labelled, randomized, parallel investigation. Randomized subjects will receive active warming with BARRIER® EasyWarm or with forced air warming. All subjects may receive rescue warming if their core temperature falls below 35.5°C. Rescue warming is optional and defined as the institution's standard of care to prevent hypothermia. The primary purpose is to investigate if there is a clinically relevant difference in core body temperature between the two treatment groups. A total of 60 subjects will be included in the investigation, i.e. 30 subjects in each treatment group. The number includes a 30% drop-out rate.

Conditions

Inadvertent Perioperative Hypothermia; Preoperative Anxiety Experienced by the Patient

Keywords

Patient warming; Active warming; Forced Air Warming; Warming blanket

Outcome Measures

Primary Outcomes (1)

• The Difference in Core Body Temperature in the Two Treatment Groups.

  Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.

  Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.

Study Arms (2)

Active self-warming blanket

EXPERIMENTAL

Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase

Device: Active self warming blanket

Forced air warming device

ACTIVE COMPARATOR

Active warming with forced air warming (FAW) during the intraoperative phase.

Device: Forced air warming device

Interventions

Active self warming blanket DEVICE

BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron.

Also known as: BARRIER® EasyWarm

Active self-warming blanket

Forced air warming device DEVICE

Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.

Also known as: Bair Hugger™, Equator® level 1.

Forced air warming device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form (ICF)
• Male and female subjects aged 18 years and over
• Subject scheduled for surgery with a minimum length of 60 minutes and a maximum length of 120 minutes
• Scheduled surgery must be performed entirely under general anaesthesia
• The subject must be able to receive temperature assessments via an oesophageal temperature probe when under general anaesthesia and via an oral thermometer before and after general anaesthesia as well as in the pre- and post-op area
• The subject must have an oral temperature measurement of at least 36.0°C when first measured in the preoperative setting
• The subject's scheduled surgical procedure must allow time to be warmed with a fully activated BARRIER® EasyWarm at least 30 minutes prior to induction of general anaesthesia

You may not qualify if:

• Subjects with an American Society of Anesthesiologists (ASA) rating of 4 or greater
• Known Diabetes with an HbA1c of more than 6 %
• Relevant medical history (e.g., neuropathy, peripheral vascular disease, circulatory disorder or other) that presents risk to/of:
• The subject's normal temperature regulation or
• Perception of external temperature or
• Subcutaneous lipoatrophy
• Current use of concomitant medications that present relevant risk to/of:
• The subject's normal temperature regulation or
• Perception of external temperature or
• Subcutaneous lipoatrophy
• Epidural/Spinal anaesthesia
• An oral temperature measurement ≥ 37.5°
• Contraindications to the oesophagus temperature probe and oral thermometer
• Presence of skin and soft tissue disorders in areas covered directly by the device in the two treatment groups (e.g. pressure ulcers, clinically significant psoriasis, dermatitis or any other interruption of skin integrity that would be affected by direct heat)
• Pregnancy

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (3)

Universitätsklinikum Gießen und Marburg GmbH

Marburg, 35043, Germany

Location

Ullevål - Oslo Universitetssykehus

Oslo, 0424, Norway

Location

Royal Hallamshire Hospital

Sheffield, S10 2SB, United Kingdom

Location

Results Point of Contact

• Title: Prof Alexander Torossian
• Organization: Universitätsklinikum Gießen und Marburg GmbH

alexander.torossian@med.uni-marburg.de

(+49) 06421 - 286 9864

Study Officials

• Alexander Torossian, Prof. MD

  Universitätsklinikum Gießen und Marburg GmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: March 5, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 13, 2015
• Results First Posted: November 13, 2015

Record last verified: 2014-06

Locations

DE (1); GB (1); NO (1)